Tai Chi based exercise program provided
Tousignant et al. Trials 2014, 15:42
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STUDY PROTOCOL
TRIALS
Open Access
Tai Chi-based exercise program provided via
telerehabilitation compared to home visits in a
post-stroke population who have returned home
without intensive rehabilitation: study protocol
for a randomized, non-inferiority clinical trial
Michel Tousignant1,2*, Hélène Corriveau1,2, Dahlia Kairy3, Katherine Berg4, Marie-France Dubois1,2, Sylvie Gosselin1,
Richard H Swartz4, Jean-Martin Boulanger1 and Cynthia Danells5
Abstract
Background: The incidence of strokes in industrialized nations is on the rise, particularly in the older population. In
Canada, a minority of individuals who have had a stroke actually receive intensive rehabilitation because most
stroke patients do not have access to services or because their motor recovery was judged adequate to return
home. Thus, there is a considerable need to organize home-based rehabilitation services for everyone who has had
a stroke. To meet this demand, telerehabilitation, particularly from a service center to the patient’s home, is a
promising alternative approach that can help improve access to rehabilitation services once patients are
discharged home.
Methods/Design: This non-inferiority study will include patients who have returned home post-stroke without
requiring intensive rehabilitation. To be included in the study, participants will: 1) not be referred to an Intensive
Functional Rehabilitation Unit, 2) have a Rankin score of 2 or 3, and 3) have a balance problem (Berg Balance Scale
score between 46 and 54). Participants will be randomly assigned to either the teletreatment group or the home
visits group. Except for the delivery mode, the intervention will be the same for both groups, that is, a personalized
Tai Chi-based exercise program conducted by a trained physiotherapist (45-minute session twice a week for eight
consecutive weeks). The main objective of this research is to test the non-inferiority of a Tai Chi-based exercise
program provided via telerehabilitation compared to the same program provided in person at home in terms of
effectiveness for retraining balance in individuals who have had a stroke but do not require intensive functional
rehabilitation. The main outcome of this study is balance and mobility measured with the Community Balance and
Mobility Scale. Secondary outcomes include physical and psychological capacities related to balance and mobility,
participants’ quality of life, satisfaction with services received, and cost-effectiveness associated with the provision of
both types of services.
Study/trial registration: ClinicalTrials.gov: NCT01848080
Keywords: Balance, Stroke, Telerehabilitation, Tai Chi exercise program, Randomized controlled trial
* Correspondence: michel.tousignant@usherbrooke.ca
1
Université de Sherbrooke, Sherbrooke, QC, Canada
2
Research Center on Aging, University Institute of Geriatrics of Sherbrooke,
Sherbrooke, QC, Canada
Full list of author information is available at the end of the article
© 2014 Tousignant et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the
Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public
Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this
article, unless otherwise stated.
Tousignant et al. Trials 2014, 15:42
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Background
The incidence of strokes in industrialized nations is on
the rise, particularly in the older population. The risk of
stroke doubles every ten years after age 55 [1]. The prognosis of functional recovery following a stroke depends
on several factors, including initial severity of the injury,
spontaneous recovery capacities and the impact of rehabilitation [2]. In older individuals, stroke sequelae can
include sensorimotor, cognitive and perceptual impairments, which directly affect mobility and balance and
thus drastically increase the risk of falls [3,4]. In fact,
balance and ambulation problems are the most important fall risk factors following a stroke [5-7]. It has been
shown that 75% of individuals who have had a stroke fall
within the first six months following their discharge
from hospital [3]. Consequently, balance is considered to
be one of the most promising reversible risk factors to
reduce falls [8,9].
In Canada, only 10 to 15% of people who have had a
stroke actually receive rehabilitation services [10]. Typically, rehabilitation is based on a multidisciplinary approach that begins during acute care and continues in
an intensive functional rehabilitation unit (IFRU) and
after discharge. However, 37% of moderate-to-severe
cases are transferred to a rehabilitation unit post-stroke
[11]; the others return home with or without rehabilitation services [12,13], either because they live too far
from a rehabilitation center or because their motor recovery was judged adequate for a safe return home
[14,15]. Thus, there is a large number of individuals at
home who need rehabilitation following their stroke but
who do not have access to services [16]. Consequently,
their mobility and balance decline, creating a significant
risk for falls in this population.
The literature supports the need for outpatient rehabilitation services, at home or elsewhere for those
who return home, regardless of the severity of their sequelae [17]. Unfortunately, the precarious nature of services has been well-documented in the Canadian Best
Practice Recommendations for Stroke Care (updated
2013); it appears that the primary obstacle hindering best
practice application in stroke care is the lack of human resources. With this in mind, the Best Practices Expert
Consensus Panel prioritized certain recommendations, including facilitating outpatient and home-based rehabilitation services because of the inability of the healthcare
system to meet current demands [18]. Therefore, it is essential to improve accessibility to rehabilitation services,
as clearly indicated in the Quebec Homecare Support Policy [18,19].
In this context, new alternative approaches need to be
considered to deliver services at home. Telerehabilitation,
defined as a telehealth application that uses telecommunication technologies to provide rehabilitation services, is a
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new approach in the rehabilitation field. It has been identified as a very promising alternative tool that could help
improve access to healthcare services in general [20-25].
Furthermore, telerehabilitation has been identified as one
of the three telehealth application areas prioritized by the
Quebec Ministry of Health and Social Services [11]. A
main advantage of this intervention method is that it allows patients to receive rehabilitation in their homes without having to travel to get healthcare services. This way of
delivering services also addresses the shortage of professionals; with less time spent traveling, professionals can
spend more time treating, which in turn improves access
to services. It is therefore crucial to provide decisionmakers with evidence concerning the effectiveness of telerehabilitation applications.
Regardless of the rehabilitation delivery mode, the
choice and type of exercise program varies from one study
to the next. Recent studies have shown that a balance
retraining program based on Tai Chi movements improved balance in individuals at risk of falls [26,27]. A Tai
Chi-based exercise program, supervised by a physiotherapist, which uses movement repetition favoring directional
adjustments in space has been shown to be effective in improving balance in individuals with physical impairments,
including those presenting sequelae following a stroke.
Two studies conducted by our research group demonstrated similar results in frail, older individuals [28,29]. A
study conducted with older individuals with diabetes
found that a simple sequence of Tai Chi movements improved their balance and attention capacity [29]. Another
study conducted with frail, older individuals with balance
problems showed that a Tai Chi intervention had a protective effect on the incidence of falls: for every person
who had falls in the Tai Chi group, the conventional
physiotherapy group had 1.3 people who had falls [29].
Furthermore, the Tai Chi intervention appeared to delay
the onset of the first fall in older individuals, with 50% of
participants in the physiotherapy group falling once after
five months of follow-up, compared to after ten months of
follow-up for 50% of participants in the Tai Chi group
[30]. Even more interesting is the fact that these balance
retraining programs based on Tai Chi movements are
equally effective in older individuals following a stroke
[31,32]. In fact, the first large-scale study [31] (Tai Chi
group: n = 74; comparison group: n = 62) demonstrated
the effectiveness of Tai Chi in improving balance compared to a conventional exercise program in individuals
with chronic stroke. A second study [32] achieved the
same results with 18 patients. Moreover, in a pre-/postintervention study with no control group, 17 balance
impaired elders have undergone a structured, interactive,
and supervised Tai Chi class from their own homes
through a videoconferencing system to improve balance
and reduce fear of falling. The results demonstrated the
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intervention was effective for improving balance and
reducing fear of falling [33]. Finally, our pilot study demonstrated that Tai Chi practiced via supervised telerehabilitation was effective in improving balance and motor skills
in six patients post-stroke.
The principal aim of this clinical trial is to test the noninferiority of a Tai Chi-based exercise program, provided
via telerehabilitation compared to the same program provided in person at home, in terms of effectiveness for
retraining balance in individuals who have had a stroke
but do not require intensive functional rehabilitation.
More specifically, the objectives are to:
1) Verify whether the gains in both physical and
psychological capacities related to balance and
mobility of patients treated by Tai Chi via
telerehabilitation are not inferior to those receiving
the same treatment in person at home;
2) Verify if the gain in quality of life of patients treated
by Tai Chi via telerehabilitation is not inferior to the
gain of those receiving the same treatment in person
at home;
3) Verify if satisfaction with services received by
patients treated by Tai Chi via telerehabilitation
group is not inferior to satisfaction of those
receiving the same treatment in person at home;
4) Compare the costs associated with the provision of
the two types of services delivery, that is, via
telerehabilitation and in person at home.
Methods/Design
Study design
The design of choice to determine the effectiveness of
an experimental intervention compared to a standard
intervention is the randomized controlled trial (RCT).
Two groups will be formed: 1) telerehabilitation group,
and 2) home visits group. We will use this design while
considering that the prerequisites for undertaking a noninferiority RCT are met:
1) The plausibility that a balance retraining program
based on Tai Chi movements has been shown to
improve balance [34], and specifically in clients with
stroke [32,35].
2) The research procedures in telerehabilitation are
well established in real-life situations, from both
clinical and technological perspectives. Our team is
at the forefront of conducting studies in home-based
teletreatment following knee arthroplasty [30,36], in
speech therapy [37], and in individuals with chronic
obstructive pulmonary disease [38].
3) We conducted a pilot study in six patients post-stroke.
Figure 1 illustrates the research design and timeline.
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Participants
The study population of interest will be individuals who
have had a stroke and stayed in a hospital linked to one of
the following sites: 1) Sherbrooke site (Centre Hospitalier
Universitaire de Sherbrooke), 2) Montreal sites (Jewish
Rehabilitation Hospital, Institut de Réadaptation GingrasLindsay-de-Montreal and Centre de Santé et de Services
Sociaux Champlain-Charles-Le Moyne), and 3) Toronto
site (Sunnybrook Health Sciences Center). Special care
will be taken to ensure that participant eligibility will target individuals who have had a stroke and returned home
without requiring intensive rehabilitation. We will base
our selection on the Rankin classification [39] established
by the treating neurologist or trained therapist during the
hospitalization period. This classification system allows us
to assign individuals who have had a stroke to one of four
groups according to their level of functional impairment.
Patients with a Rankin score of 2 generally present with
mild impairments, maintain their autonomy and can perform all previous activities. Patients with a Rankin score
of 3 present with moderate impairments and generally require moderate assistance with their activities of daily living. These patients are usually sent home with or without
referral for physiotherapy services at home.
Therefore, a sample of participants aged 45 years and
older will be recruited based on the following inclusion
criteria: 1) have had a stroke with a Rankin score of 2 or 3;
2) not be referred to an IFRU and return home following
discharge from hospital; 3) understand instructions to
allow participation in evaluations and interventions; 4)
have a balance problem as evidenced by a score between
46 and 54 on the Berg Balance Scale [40]; 5) have a caregiver who would be available during the telerehabilitation
sessions to ensure safety during exercises; and 6) live in an
area served by high speed Internet. Excluded will be individuals who present with: 1) a previous stroke episode in
the last 12 months (other than the present one); 2) severe
body hemineglect; 3) significant hemianopsia visual problems accompanied by hemineglect; 4) uncontrolled medical problems; and 5) moderate to severe aphasia.
Participants will be recruited during the hospitalization
period by the team of treating nurses, physiotherapists
and neurologists at each of the three sites (Sherbrooke,
Montreal and Toronto). When the team decides that a patient will not require a referral to an IFRU and will return
home (inclusion criteria 1 and 2), they will verify inclusion
criteria 3 and 4 and exclusion criteria 1 to 5 from the
medical chart. If patients are eligible based on these criteria, the hospital team will ask if they agree to be contacted by a research associate. If they agree, a research
associate will visit them in hospital to inform them of the
project and ask them to participate. The research associate
will verify inclusion criteria 5 and 6. If a patient meets all
the criteria and is interested in participating in the study,
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Figure 1 Research design and timeline.
they will be asked to sign the consent form previously approved by the ethics committee at each recruitment site.
Once included, participants will be randomly assigned
to either the telerehabilitation group or the home
visits group by the coordinator of each recruitment
site. This randomization will be performed using block
randomization of sizes 2 and 4 done by a computer. Block
size will not be known by the evaluators. This randomization will be performed following stratification
based on the Rankin score (2 or 3), a variable that is likely
to influence recovery prognosis. A system of numbered,
sealed envelopes will be put in place.
Ethics
The study is being conducted in accordance with the
Helsinki Declaration. It was approved by the Ethics Committee of each recruitment sites: 1) Sherbrooke - Centre
Hospitalier Universitaire de Sherbrooke and Centre de
Santé et de Services Sociaux de l’Institut Universitaire
de Gériatrie de Sherbrooke; 2) Montréal - Centre de
Recherche Interdisciplinaire en Réadaptation de Montréal
Métropolitain; 3) Longueuil - Centre de Santé et de Services Sociaux Champlain-Charles-Le Moyne; 4) Toronto Sunnybrook Hospital. It has also been registered under
www.clinicaltrials.gov (NCT01848080).
Interventions
A personalized exercise program based on Tai Chi was
developed by our team for previous studies aiming to
improve balance in older individuals with diabetes [28]
and in frail, older individuals with balance problems
[29]. This program was also used during the pilot study.
The exercise program consists of movements based on a
combination of alignments and body-specific orientations, weight transfers and changes in direction inspired
by Tai Chi [41]. The exercises do not require any physical interaction between the Tai Chi instructor and participants. Optimal treatment frequency for patients in
the subacute and chronic phases following a stroke is
twice a week, as suggested by a systematic review [42].
For both groups, the interventions will start immediately after discharge from hospital. The rehabilitation
exercise sessions will be conducted by a physiotherapist
trained in the practice of Tai Chi. The sessions will last
45 minutes and take place twice a week for eight weeks.
The only difference between the groups will be the delivery mode of the intervention, that is telerehabilitation or
home visits.
Outcomes
All evaluations will be completed in the research centers/
hospitals of the three sites and will last approximately
three hours. The first evaluation will be conducted at
baseline, prior to starting intervention (T1) to collect base
measures on the participants’ condition. A second evaluation will be conducted just after the two-month intervention (T2) and the third evaluation will be four months (T3)
following discharge from the hospital. All evaluations will
be carried out by evaluators trained in the standard procedures for all measures, who are independent and blinded
to the intervention. Specific directions will be provided to
the evaluators and the participants to ensure that intervention allocation remains anonymous.
To measure balance and functional mobility, the Community Balance and Mobility Scale (CB&M) [43-45] will
be used. This tool was developed for ambulatory individuals following a traumatic brain injury [43]. It has been
validated in individuals following a stroke [44,46]. It assesses 19 tasks. The items are rated on a six-point scale
(from 0 = unable to perform, to 5 = able to perform independently), for a maximum total score of 95 points. The
CB&M has demonstrated good intra-rater, inter-rater and
test-retest reliability (ICC = 0.98 for all three cases) and
high internal consistency (Cronbach’s alpha = 0.96) [43]. It
has good convergent validity with the Chedoke-McMaster
Stroke Assessment [47] for leg and foot (r = 0.61 and 0.63,
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respectively) and for lower extremity strength (r = 0.67)
[44]. Furthermore, the CB&M has been shown to be
sensitive to change from baseline at follow-up in
community-dwelling, ambulatory individuals post-stroke
(SRM (standardized response mean) = 0.83) [44]. In
addition, the Berg Balance Scale [42,48] will be used to
evaluate balance in patients. The Four-Squares Test will
also be used. This test consists of moving in different preset directions: forward, backward and to the sides. The
time required to complete the sequence is recorded. An
execution time greater than 15 seconds is predictive of
falling. This test has high inter-rater (ICC = 0.99), intrarater (ICC = 0.98) and test-retest (ICC = 0.98) reliability in
community-dwelling older individuals aged 65 years and
over [49]. Also, for predicting falls, this test has good
specificity ranging from 88% to 100% and a positive predictive value of 86% [49].
The physical abilities capacities measured will be:
1) walking speed, 2) walking endurance, 3) lower extremity strength, and 6) lower extremity movement capacity.
Each of these abilities plays an important role in achieving
optimal functional mobility. Walking speed will be evaluated using the Timed Up and Go test (TUG) [50]. The test
consists of standing up from a chair, walking a distance of
three meters, turning around and returning to the chair to
sit down again. The test is timed to measure walking
speed in seconds over a distance of six meters. The TUG
demonstrates good convergent construct validity with
moderate to strong correlations with walking using the
Tinetti test (r = 0.53) and walking speed (r = 0.66) in an elders population aged 65 years and over [51]. It has also
been shown that walking speed is related to use of gait
aids and fall frequency [52]. It is a measure sensitive to
change [53]. Walking endurance will be estimated by the
distance covered in meters during the Two-Minute Walk
Test [53,54]. The inter-rater and intra-rater reliability of
this test is high (ICC = 0.99) [50]. General lower extremity
strength will be measured with the Sit to Stand test (STS)
[55]. The time required to complete five successive ‘sit-tostand’ repetitions will be recorded [55,56]. The test-retest
reliability of the STS is high (ICC = 0.89) [57]. There is
also a strong correlation of the STS with walking speed
over five meters (r = −0.66) and lower extremity strength
(r = 0.47) [58]. Lower extremity movement capacity and
postural control will be evaluated using the ChedokeMcMaster Stroke Assessment [59]. The impairment inventory determines the presence and severity of physical
deficits, and allows patients to be classified according to
Brunnstrom’s seven stages of motor recovery. This tool
has good intra- and inter-rater reliability (ICC = 0.98 and
0.97, respectively) and good construct validity (r > 0.60
with different aspects of the Fugl Meyer test) [47].
Two main aspects of psychological capacities measured will be 1) fear of falling, and 2) self-efficacy. The
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simplified version of the Activities-specific Balance
Confidence (ABC) scale [60] questionnaire (ABC-S) will
measure fear of falling. This questionnaire includes 15
questions rated on a four-point Likert scale and evaluates an individual’s balance confidence during a series of
daily activities [60,61]. The ABC-S has strong internal
consistency (Cronbach’s alpha = 0.86) good convergent
validity with significant associations with balance and
occurrence of falls [60]. Self-efficacy when faced with
difficult life situations will be evaluated using the Generalized Self-Efficacy Scale (GSES) [60]. This questionnaire
is a ten-item scale that uses a four-point Likert scale
(from 1 = not true at all, to 4 = completely true) to assess
whether an individual believes that their actions are
responsible for their successful outcomes. This scale has
been shown to have excellent internal consistency
(Cronbach’s alpha = 0.86) [62].
Quality of life will be measured using the Reintegration to Normal Living Index (RNLI) [63]. This tool consists of 11 items ranked on a three-point Likert scale.
The total score ranges from 0 to 22, with higher scores
depicting lower quality of life. The psychometric properties range from very good to excellent with good internal
consistency (Cronbach’s alpha = 0.90) and good testretest reliability (r = 0.83) [63]. The construct validity of
this tool has been examined in a post-stroke population
and shows excellent correlations with the Frenchay Activities Index (r = 0.69) and the Short Form 36 Health
Survey (r = 0.74) [64].
Participant satisfaction with the intervention received
will be evaluated using the Health Care Satisfaction
Questionnaire, a questionnaire developed and validated
in French [65]. The satisfaction construct is determined
by three distinct factors which include satisfaction with:
1) the therapist relationship, 2) the services provided,
and 3) the organization of services. This tool includes 26
questions, scored on a four-point Likert scale. The total
score is calculated based on average satisfaction for the
three factors, with higher scores indicating higher levels
of satisfaction. Test-retest reliability is documented by
an ICC of 0.72 and internal consistency by a Cronbach’s
alpha of 0.93 for the entire scale [65].
A modified version of the ‘Cost analysis of telemedicine’
table from the University of Minnesota [66] will help tabulate the costs associated with the teletreatments. These
costs will be calculated to establish a cost differential (that
is, cost-effectiveness) between the two different types of
intervention. The method for collecting this data has
already been tested in a previous study [67]. The variables
related to the total cost include those associated with the
actual intervention (for example, direct and indirect time
for the intervention, professionals’ travel time to the participants’ homes, telerehabilitation equipment, and Internet service including installation and set-up).
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The typical sociodemographic (for example, age, sex,
marital status, living environment, education, primary occupation) and clinical characteristics (for example, diagnosis, gait aid, medications, self-rated health, co-morbidities)
will be collected using an in-house questionnaire, with the
exception of comorbidities for which the Functional Comorbidity Index will be used [68].
The level of impairment post-stroke will be measured
by the National Institute of Health Stroke Score (NIHSS)
[69,70]. This questionnaire, administered by a healthcare
professional, includes 15 items to evaluate patients in the
acute post-stroke phase. It demonstrates good internal
consistency (Cronbach’s alpha > 0.5) [71], good inter-rater
(ICC = 0.69) and test-retest (ICC = 0.66 to 0.77) reliability
in a post-stroke population [69] and good convergent validity (r = 0.74 with lesion volume seven days post-stroke)
[70]. The level of cognitive impairment will be measured
using the Montreal Cognitive Assessment (MoCA) [72].
This test evaluates attention, concentration, executive
functions, memory, language, visioconstructive capacities,
abstraction capacities, calculation and orientation. The
maximum score of 30 corresponds to no cognitive problems. The internal consistency of this test is good
(Cronbach’s alpha = 0.83) and test-retest reliability is excellent (ICC = 0.92) [73]. The correlation between the
MoCA and Mini-Mental State Examination scores has
been shown to be excellent (r = 0.87) [73]. Noteworthy
is the fact that this test will be completed during the
participant recruitment phase.
Statistical methods
We expect to recruit 240 participants, that is, 120 per
group. Allowing for a drop-out rate of 10%, this sample
size will provide a power of 80% to demonstrate the
non-inferiority of Tai Chi provided by telerehabilitation
compared to Tai Chi provided in person at home, with a
two-group one-sided test at the 2.5% level (nQuery
Advisor 7.0; Statistical Solutions, Boston, MA). For this
calculation, the non-inferiority limit was set at four points
on the CB&M scale and the standard deviation of the gain
was estimated to be 10.4, based on findings from Knorr
[44], since SRM = MeanGAIN/sGAIN implies that:
SGAIN ¼ MeanGAIN =SRM ¼ ð51:3−42:7Þ=0:83
First, we will describe the characteristics of each group
pre-intervention using averages and standard deviations
(continuous variables) or percentages (categorical variables). The groups will then be compared using a t-test
or chi-squared test. If the groups differ on certain characteristics pre-intervention despite randomization, subsequent analyses will account for these differences.
Primary analysis will aim to test the non-inferiority of
Tai Chi provided via telerehabilitation compared to Tai
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Chi provided in person at home as evaluated by score
gains on the CB&M questionnaire from T1 to T2. Delivery by telerehabilitation will be regarded as non-inferior
to in person home delivery if the upper limit of the
unilateral confidence interval around the difference in
gains between the two groups is less than 4. This noninferiority limit was set below the CB&M’s minimal clinically significant difference of five points. It is recommended
to choose a non-inferiority limit less than the difference
judged to be clinically significant [74,75].
The same analytical strategy will be used to evaluate
and compare the effectiveness of the interventions on
secondary variables and to compare maintenance over
time (that is, the confidence interval around the difference between the two groups from T1 to T3) across all
variables. A more conservative level of significance will
be used to account for the numerous tests.
All analyses will first be performed according to the
treatment received (per protocol = PP) and according to
the assigned group (intention to treat = ITT), requiring
that non-inferiority be shown in both cases since ITT
analyses increase the chance of declaring non-inferiority
if the two delivery modes produce a similar pattern of
withdrawal, while PP analyses bias towards the null in
presence of a different pattern of withdrawal [74]. For
the ITT analysis, the effects of withdrawal or low levels
of compliance will be explored with sensitivity analyses,
where the missing data will be replaced with extreme
values (that is, no change following treatment - the most
favorable change noted in the study). Any non-robustness
of results revealed by the comparison of strategies will be
noted and the caveats will be mentioned in the discussion
of results. All analyses will be conducted at the end of the
study since the proposed treatments are of short duration
and involve minimal risk to the participants.
The economic analysis will be a type of costminimization study [76]. Assuming that the effectiveness
will be the same in the dependent variable (CB&M), the
cost will be determined for the two groups and the cost
differential will be established.
Discussion
This trial is the first large-scale study to evaluate the noninferiority of telerehabilitation versus home visits in patients with mild to moderate balance impairment poststroke. Confirmation to recruit as many as 240 patients
post-stroke with our inclusion/exclusion criteria is based
on the 2010 to 2011 statistics for each recruitment site: 1)
Centre Hospitalier Universitaire de Sherbrooke (269 participants admitted following a stroke, including 59 who
returned home upon discharge); 2) Jewish Rehabilitation
Hospital (277 referrals for patients post-stroke); 3) Centre
de Santé et de Services Sociaux Champlain-Charles-Le
Moyne (106 participants admitted following a stroke,
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including 60 who returned home upon discharge); 4)
Toronto (189 participants admitted following a stroke, including 49 who returned home upon discharge). These
well-documented statistics proved the realism of the scope
of the study.
Telehealth, which includes telerehabilitation, is seen as
a method to provide care to the population. Considering
that the criteria for quality of care remain the same regardless of whether the care is provided by telehealth or
other means, the evaluation framework of the proposed
research is based on the theoretical construct of quality
of care. Without formal definition [77], quality of care
encompasses two components: 1) the viewpoint of the
patient who considers the notions of accessibility and effectiveness as essential [78]; and 2) the viewpoint of the
professional for whom the patient-doctor relationship [79],
efficiency and reliability are of key importance. Several
conceptual models for evaluating quality of care in the
literature include the Donabedian [80], Total Quality Management [81], Quality-Caring [82], ORYX [80], HEDIS [83]
and CONQUEST [80] models. In this research project, the
conceptual evaluation model used will be the Donabedian
model [84]. Given the objectives of this project, the study
aims to answer specific questions related to the effectiveness of using telerehabilitation to improve quality of care
for older individuals. This model defines quality of care as
a combination of three elements: structure, process and
outcome. The notions of ‘quality’ and ‘performance’ are
directly related to the organizational structure of the
healthcare system and its management processes. The term
‘outcome’ corresponds to the quality of care provided to
patients, the performance of the healthcare system in offering care and the associated costs. Given the nature of this
research, emphasis will be placed on the evaluation of telerehabilitation outcomes.
Concerning internal validity, we will control for potential selection bias by assigning participants to either the
telerehabilitation or the control (home visits) group by
randomization and by comparing participants’ characteristics in each group before the intervention. If the groups
have different characteristics pre-intervention despite
randomization, subsequent analysis will account for these
differences. Information bias will be controlled by using
standardized measures and by calibrating all the assessors
for each assessment.
This study will verify the non-inferiority of in-home telerehabilitation compared to home visits for patients with
mild to moderate balance problems post-stroke. Our hypothesis is that in-home telerehabilitation will be shown
to be a good alternative to ensure continuity of rehabilitation services and their accessibility in the community.
Trial status
Recruitment has just begun (September 2013).
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Abbreviations
ABC-S: Activities-specific Balance Confidence scale (Simplified version);
CB&M: Community Balance and Mobility Scale; GSES: Generalized Self-Efficacy
Scale; ICC: intra-class correlation; IFRU: Intensive Functional Rehabilitation
Unit; ITT: intention to treat; MoCA: Montreal Cognitive Assessment;
NIHSS: National Institute of Health Stroke Score; PP: per protocol;
RCT: randomized controlled trial; RNLI: Reintegration to Normal Living Index;
SRM: standardized response mean; STS: Sit to Stand test; TUG: Timed Up and
Go test.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
All authors participated in the conception and design of the study. MT is
responsible for telerehabilitation expertise. HC and KB are responsible for fall
prevention, balance expertise and intervention program. SG and RS are the
neurologists taking care of recruitment. DK carries out the cost evaluation.
MFD carries out the statistical analysis. JMB and CD supervised the team of
research agents at their sites. All authors read and approved the final
manuscript.
Acknowledgements
This research project is support by a grant received from the Canadian
Institute of Health Research (CIHR), CIHR grant #272977.
Author details
1
Université de Sherbrooke, Sherbrooke, QC, Canada. 2Research Center on
Aging, University Institute of Geriatrics of Sherbrooke, Sherbrooke, QC,
Canada. 3Université de Montréal, Montreal, QC, Canada. 4University of
Toronto, Toronto, ON, Canada. 5Sunnybrook Stroke Research Unit, Toronto,
ON, Canada.
Received: 3 October 2013 Accepted: 22 January 2014
Published: 30 January 2014
References
1. Sacco RL, Benjamin EL, Broderick JP, Dyken M, Eston JD, Feinberg WM,
Goldstein LB, Gorelick PB, Howard G, Kittner SJ, Manolio TA, Whisnant JP,
Wolf PA: American Heart Association Prevention Conference. IV.
Prevention and Rehabilitation of Stroke. Risk factors. Stroke 1997,
28(7):1507.
2. Dimyan MA, Cohen LG: Neuroplasticity in the context of motor
rehabilitation after stroke. Nat Rev Neurol 2011, 7(2):76.
3. Forster A, Young J: Stroke rehabilitation: can we do better? BMJ 1992,
305(6867):1446.
4. Wada N, Sohmiya M, Shimizu T, Okamoto K, Shirakura K: Clinical analysis of
risk factors for falls in home-living stroke patients using functional
evaluation tools. Arch Phys Med Rehabil 2007, 88(12):1601.
5. Stolze H, Klebe S, Zechlin C, Baecker C, Friege L, Deuschl G: Falls in
frequent neurological diseases - prevalence, risk factors and etiology.
J Neurol 2004, 251(1):79.
6. Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM, Women's Health and
Aging Study: Risk factors for falling in home-dwelling older women with
stroke: the Women's Health and Aging Study. Stroke 2003, 34(2):494.
7. Simpson LA, Miller WC, Eng JJ: Effect of stroke on fall rate, location and
predictors: a prospective comparison of older adults with and without
stroke. PloS One 2011, 6(4):e19431.
8. Tinetti ME, Baker DI, Dutcher J, Vincent JE, Rozett RT: Reducing the risk of
falls among older adults in the community. Berkeley, CA: Peaceable Kingdom
Press; 1997.
9. Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson
LM, Lamb SE: Interventions for preventing falls in older people living in
the community. Cochrane Database Syst Rev 2012, 9, CD007146.
10. Lincoln NB, Gladman JR, Berman P, Luther A, Challen K: Rehabilitation
needs of community stroke patients. Disabil Rehabil 1998, 20(12):457–463.
11. Canadian Stroke Network: La qualité des soins de l'AVC au Canada. http://
www.canadianstrokenetwork.ca/wp-content/uploads/2011/06/QoSC-FR1.pdf.
12. Bates B, Choi JY, Duncan PW, Glasberg JJ, Graham GD, Katz RC, Lamberty K,
Reker D, Zorowitz R, US Department of Defense; Department of Veterans
Affairs: Veterans Affairs/Department of Defense Clinical Practice
Tousignant et al. Trials 2014, 15:42
http://www.trialsjournal.com/content/15/1/42
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
Guideline for the Management of Adult Stroke Rehabilitation Care:
executive summary. Stroke 2005, 36(9):2049.
Edwards DF, Hahn MG, Baum CM, Perlmutter MS, Sheedy C, Dromerick AW:
Screening patients with stroke for rehabilitation needs: validation of the
post-stroke rehabilitation guidelines. Neurorehabil Neural Repair 2006, 20(1):42.
Mayo NE, Wood-Dauphinee S, Côté R, Durcan L, Carlton J: Activity,
participation, and quality of life six months poststroke. Arch Phys Med
Rehabil 2002, 83(8):1035.
Chuang KY, Wu SC, Ma AH, Chen YH, Wu CL: Identifying factors associated
with hospital readmissions among stroke patients in Taipei. J Nurs Res
2005, 13(2):117.
Thorsen AM, Holmqvist LW, de Pedro-Cuesta J, von Koch L: A randomized
controlled trial of early supported discharge and continued rehabilitation
at home after stroke: five-year follow-up of patient outcome.
Stroke 2005, 36(2):297.
Lindsay P, Bayley M, Hellings C, Hill M, Woodbury E, Philips S:
Recommandations canadiennes pour les pratiques optimales de soins
de l'AVC (mise à jour de 2008) - Sommaire. CMAJ 2008, 179(12):SF1.
Ministère de la santé et des services sociaux du Québec: Chez soi: le
premier choix. La politique de soutien à domicile. http://publications.
msss.gouv.qc.ca/acrobat/f/documentation/2002/02-704-01.pdf.
Ministère de la santé et des services sociaux du Québec: Chez soi: le
premier choix. Précisions pour favoriser l'implantation de la politique de
soutien à domicile. http://publications.msss.gouv.qc.ca/acrobat/f/
documentation/2004/04-704-01.pdf.
Hogenbirk JC, Brockway PD, Finley J, Jennett P, Yeo M, Parker-Taillon D,
Pong RW, Szpilfogel CC, Reid D, MacDonald-Rencz S, Cradduck T: Framework
for Canadian telehealth guidelines: summary of the environmental scan.
J Telemed Telecare 2006, 12(2):64.
Pineau G, Moqadem K, St-Hilaire C, Levac E, Hamel BT: Lignes directrices
cliniques et normes technologiques en téléréadpatation, in Agences des
technologies et des modes d'intervention en santé. http://www.inesss.qc.
ca/fileadmin/doc/AETMIS/Rapports/Telesante/2006_03_res_fr.pdf.
Brennan D, Mawson S, Brownsell S: Telerehabilitation: enabling the
remote delivery of healthcare, rehabilitation, and self management.
Stud Health Technol Inform 2009, 145:231.
McCue M, Fairman A, Pramuka M: Enhancing quality of life through
telerehabilitation. Phys Med Rehabil Clin N Am 2010, 21(1):195.
Theodoros D, Russell T: Telerehabilitation: current perspectives.
Stud Health Technol Inform 2008, 131:191.
Romanow RJ: L'Avenir des soins de santé au Canada. http://publications.
gc.ca/collections/Collection/CP32-85-2002F.pdf.
Wong AM, Yu-Cheng P, Ching L, Shu-Chun H, Yin-Chou L, Shih-Wei C: Is Tai
Chi Chuan effective in improving lower limb response time to prevent
backward falls in the elderly? Age (Dordr) 2009, 31(2):163.
Sattin RW, Sley KA, Wolf SL, Chen Y, Kutner MH: Reduction in fear of falling
through intense Tai Chi exercise training in older, transitionally frail
adults. J Am Geriatr Soc 2005, 53:1168.
Corriveau H, Sveistrup H, Tousignant M: Effects of Tai Chi Exercise on Clinical
Measures of Balance and Attention Demand in Older Individuals with
Moderate Diabetic Peripheral Neuropathy. Burlingon (USA): Proceedings of
Symposium International of gait and posture: 3 to 5 July 2007; 2007.
Tousignant M, Corriveau H, Roy PM, Desrosiers J, Dubuc N, Hébert R:
Efficacy of supervised Tai Chi exercises versus conventional physical
therapy exercises in fall prevention for frail older adults: a randomized
controlled trial. Disabil Rehabil 2012, 35(17):1429.
Tousignant M, Corriveau H, Roy PM, Desrosiers J, Dubuc N, Hébert R,
Tremblay-Boudreault V, Beaudoin AJ: The effect of supervised Tai Chi
intervention compared to a physiotherapy program on fall-related clinical
outcomes: a randomized clinical trial. Disabil Rehabil 2012, 34(3):196.
Au-Yeung S, Hui-Chan CW, Tang JC: Short-form Tai Chi improves standing
balance of people with chronic stroke. Neurorehabil Neural Repair 2009,
23(5):515–522.
Har J, Kanner H, Gilboa-Mayo R, Haroeh-Peer O, Rozenthul-Sorokin N, Eldar
R: Tai Chi Chuan practice in community-dwelling persons after stroke.
Int J Rehabil Res 2004, 27(4):303.
Wu G, Keyes LM: Group tele-exercise for improving balance in elders.
Telemed J E Health 2006, 12:561–570.
Wooton A: An integrative review of Tai Chi research: an alternative form
of physical activity to improve balance and prevent falls in older adults.
Orthop Nurs 2010, 29(2):108.
Page 8 of 9
35. Bashshur R, Shannon G, Krupinski E, Grigsby J: The taxonomy of
telemedicine. Telemed J E Health 2011, 17(6):484.
36. Tousignant M, Boissy P, Moffet H, Corriveau H, Cabana F, Marquis F, Simard
J: Patients' satisfaction of healthcare services and perception with inhome telerehabilitation and physiotherapists' satisfaction toward
technology for post-knee arthroplasty: an embedded study in a
randomized trial. Telemed J E Health 2011, 17(5):376.
37. Dechêne L, Tousignant M, Boissy P, Macoir J, Héroux S, Hamel M, Brière S,
Pagé C: Simulated in-home teletreatment for anomia. Int J Telerehabil
2011, 3(2):3.
38. Tousignant M, Marquis N, Pagé C, Imukuze N, Métivier A, St-Onge V,
Tremblay A: In-home telerehabilitation for older persons with chronic
obstructive pulmonary disease: a pilot Study. Int J Telerehabil 2012, 4(1):7.
39. Lai SM, Duncan PW: Stroke recovery profile and the Modified Rankin
assessment. Neuroepidemiology 2001, 20(1):26.
40. Berg K, Wood-Dauphinee S, Williams J: The Balance Scale: reliability
assessment with elderly residents and patients with an acute stroke.
Scand J Rehabil Med 1995, 27(1):27.
41. Wolf SL, Coogler C, Xu T: Exploring the basis for Tai Chi Chuan as a
therapeutic exercise approach. Arch Phys Med Rehabil 1997, 78(8):886.
42. Lubetzky-Vilnai A, Kartin D: The effect of balance training on balance
performance in individuals poststroke: a systematic review. J Neurol Phys
Ther 2010, 34(3):127.
43. Howe JA, Inness EL, Venturini A, Williams JI, Verrier MC: The Community
Balance and Mobility Scale - a balance measure for individuals with
traumatic brain injury. Clin Rehabil 2006, 20(10):885.
44. Knorr S, Brouwer B, Garland SJ: Validity of the Community Balance and
Mobility Scale in community-dwelling persons after stroke. Arch Phys Med
Rehabil 2010, 91(6):890.
45. Salbach NM, Mayo NE, Higgins J, Ahmed S, Finch LE, Richards CL:
Responsiveness and predictability of gait speed and other disability
measures in acute stroke. Arch Phys Med Rehabil 2001, 82(9):1204.
46. Rocque R, Bartlett D, Brown J, Garland SJ: Influence of age and gender of
healthy adults on scoring patterns on the Community Balance and
Mobility Scale. Physiother Can 2005, 57:285.
47. Gowland C, Stratford P, Ward M, Moreland J, Torresin W, Van Hullenaar S,
Sanford J, Barreca S, Vanspall B, Plews N: Measuring physical impairment
and disability with the Chedoke-McMaster Stroke Assessment.
Stroke 1993, 24(1):58.
48. Blum L, Korner-Bitensky N: Usefulness of the Berg Balance Scale in stroke
rehabilitation: a systematic review. Physical therapy 2008, 88(5):559.
49. Dite W, Temple VA: A clinical test of stepping and change of direction to
identify multiple falling older adults. Arch Phys Med Rehabil 2002,
83(11):1566.
50. Podsiadlo D, Richardson S: The timed ‘Up & Go’: a test of basic functional
mobility for frail elderly persons. J Am Geriatr Soc 1991, 39(2):142.
51. Lin MR, Hwang HF, Hu MH, Wu HD, Wang YW, Huang FC: Psychometric
comparisons of the timed up and go, one-leg stand, functional reach,
and Tinetti balance measures in community-dwelling older people. J Am
Geriatr Soc 2004, 52(8):1343.
52. Wade DT, Wood VA, Heller A, Maggs J, Langton Hewer R: Walking after
stroke. Measurement and recovery over the first three months. Scand J
Rehabil Med 1987, 19(1):25.
53. Dean CM, Richards CL, Malouin F: Walking speed over 10 meters
overestimates locomotor capacity after stroke. Clin Rehabil 2001, 15(4):415.
54. Wade DT: Measurement in neurological rehabilitation. Curr Opin Neurol
Neurosurg 1992, 5(5):682.
55. Bohannon RW: Sit-to-stand test for measuring performance of lower
extremity muscles. Percept Mot Skills 1995, 80(1):163.
56. Csuka M, McCarty DJ: Simple method for measurement of lower
extremity muscle strength. Am J Med 1985, 78(1):77.
57. Lord SR, Murray SM, Chapman K, Munro B, Tiedemann A: Sit-to-stand
performance depends on sensation, speed, balance, and psychological
status in addition to strength in older people. J Gerontol A Biol Sci Med Sci
2002, 57(8):M539.
58. Newcomer KL, Krug HE, Mahowald ML: Validity and reliability of the
timed-stands test for patients with rheumatoid arthritis and other
chronic diseases. J Rheumatol 1993, 20(1):21.
59. Valach L, Signer S, Hartmeier A, Hofer K, Steck GC: Chedoke-McMaster
stroke assessment and modified Barthel Index self-assessment in
patients with vascular brain damage. Int J Rehabil Res 2003, 26(2):93.
Tousignant et al. Trials 2014, 15:42
http://www.trialsjournal.com/content/15/1/42
60. Filiatrault J, Gauvin L, Fournier M, Parisien M, Robitaille Y, Laforest S,
Corriveau H, Richard L: Evidence of the psychometric qualities of a
simplified version of the Activities-specific Balance Confidence scale for
community-dwelling seniors. Arch Phys Med Rehabil 2007, 88(5):664.
61. Jorstad EC, Hauer K, Becker C, Lamb SE, ProFaNE Group: Measuring the
psychological outcomes of falling: a systematic review. J Am Geriatr Soc
2005, 53(3):501.
62. Scholz U, Gutiérrez-Doña B, Sud S, Schwarzer R: Is general self-efficacy a
universal construct? Psychometric findings from 25 countries. Eur J
Psychol Ass 2002, 18(3):242.
63. Wood-Dauphinee SL, Opzoomer MA, Williams JI, Marchand B, Spitzer WO:
Assessment of global function: the Reintegration to Normal Living Index.
Arch Phys Med Rehabil 1988, 69(8):583.
64. Daneski K, Coshall C, Tilling K, Wolfe CD: Reliability and validity of a postal
version of the Reintegration to Normal Living Index, modified for use
with stroke patients. Clin Rehabil 2003, 17(8):835.
65. Gagnon M, Hebert R, Dubé M, Dubois MF: Development and validation of
an instrument measuring individual empowerment in relation to
personal health care: the Health Care Empowerment Questionnaire
(HCEQ). Am J Health Promot 2006, 20(6):429.
66. Chapko MK, Hedrick S: Cost as a study outcome: sensitivity of study
conclusions to the method of estimating cost. Med Care 1999,
37(4 Suppl Va):AS37.
67. Tousignant M, Moffet H, Boissy B, Cooriveau H, Cabana F, Marquis F: A
randomized controlled trial of home telerehabilitation for post-knee
arthroplasty. J Telemed Telecare 2011, 17(4):195.
68. Groll DL, To T, Bombardier C, Wright JG: The development of a
comorbidity index with physical function as the outcome. J Clin
Epidemiol 2005, 58(6):595.
69. Brott T, Adams JR, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J,
Holleran R, Eberle R, Hertzberg V: Measurements of acute cerebral
infarction: a clinical examination scale. Stroke 1989, 20:864–870.
70. Lyden P, Brott T, Tilley B, Welch KM, Mascha EJ, Levine S, Haley EC, Grotta J,
Marler J: Improved reliability of the NIH Stroke Scale using video training.
NINDS TPA Stroke Study Group. Stroke 1994, 25(11):2220.
71. Goldstein LB, Bertels C, Davis JN: Interrater reliability of the NIH stroke
scale. Arch Neurol 1989, 46(6):660.
72. Pendlebury ST, Cuthbertson FC, Welch SJ, Mehta Z, Rothwell PM:
Underestimation of cognitive impairment by Mini-Mental State Examination
versus the Montreal Cognitive Assessment in patients with transient ischemic
attack and stroke: a population-based study. Stroke 2010,
41(6):1290.
73. Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I,
Cummings JL, Chertkow H: The Montreal Cognitive Assessment, MoCA: a
brief screening tool for mild cognitive impairment. J Am Geriatr Soc 2005,
53(4):695.
74. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG, CONSORT Group:
Reporting of noninferiority and equivalence randomized trials: extension
http://www.trialsjournal.com/content/15/1/42
STUDY PROTOCOL
TRIALS
Open Access
Tai Chi-based exercise program provided via
telerehabilitation compared to home visits in a
post-stroke population who have returned home
without intensive rehabilitation: study protocol
for a randomized, non-inferiority clinical trial
Michel Tousignant1,2*, Hélène Corriveau1,2, Dahlia Kairy3, Katherine Berg4, Marie-France Dubois1,2, Sylvie Gosselin1,
Richard H Swartz4, Jean-Martin Boulanger1 and Cynthia Danells5
Abstract
Background: The incidence of strokes in industrialized nations is on the rise, particularly in the older population. In
Canada, a minority of individuals who have had a stroke actually receive intensive rehabilitation because most
stroke patients do not have access to services or because their motor recovery was judged adequate to return
home. Thus, there is a considerable need to organize home-based rehabilitation services for everyone who has had
a stroke. To meet this demand, telerehabilitation, particularly from a service center to the patient’s home, is a
promising alternative approach that can help improve access to rehabilitation services once patients are
discharged home.
Methods/Design: This non-inferiority study will include patients who have returned home post-stroke without
requiring intensive rehabilitation. To be included in the study, participants will: 1) not be referred to an Intensive
Functional Rehabilitation Unit, 2) have a Rankin score of 2 or 3, and 3) have a balance problem (Berg Balance Scale
score between 46 and 54). Participants will be randomly assigned to either the teletreatment group or the home
visits group. Except for the delivery mode, the intervention will be the same for both groups, that is, a personalized
Tai Chi-based exercise program conducted by a trained physiotherapist (45-minute session twice a week for eight
consecutive weeks). The main objective of this research is to test the non-inferiority of a Tai Chi-based exercise
program provided via telerehabilitation compared to the same program provided in person at home in terms of
effectiveness for retraining balance in individuals who have had a stroke but do not require intensive functional
rehabilitation. The main outcome of this study is balance and mobility measured with the Community Balance and
Mobility Scale. Secondary outcomes include physical and psychological capacities related to balance and mobility,
participants’ quality of life, satisfaction with services received, and cost-effectiveness associated with the provision of
both types of services.
Study/trial registration: ClinicalTrials.gov: NCT01848080
Keywords: Balance, Stroke, Telerehabilitation, Tai Chi exercise program, Randomized controlled trial
* Correspondence: michel.tousignant@usherbrooke.ca
1
Université de Sherbrooke, Sherbrooke, QC, Canada
2
Research Center on Aging, University Institute of Geriatrics of Sherbrooke,
Sherbrooke, QC, Canada
Full list of author information is available at the end of the article
© 2014 Tousignant et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the
Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public
Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this
article, unless otherwise stated.
Tousignant et al. Trials 2014, 15:42
http://www.trialsjournal.com/content/15/1/42
Background
The incidence of strokes in industrialized nations is on
the rise, particularly in the older population. The risk of
stroke doubles every ten years after age 55 [1]. The prognosis of functional recovery following a stroke depends
on several factors, including initial severity of the injury,
spontaneous recovery capacities and the impact of rehabilitation [2]. In older individuals, stroke sequelae can
include sensorimotor, cognitive and perceptual impairments, which directly affect mobility and balance and
thus drastically increase the risk of falls [3,4]. In fact,
balance and ambulation problems are the most important fall risk factors following a stroke [5-7]. It has been
shown that 75% of individuals who have had a stroke fall
within the first six months following their discharge
from hospital [3]. Consequently, balance is considered to
be one of the most promising reversible risk factors to
reduce falls [8,9].
In Canada, only 10 to 15% of people who have had a
stroke actually receive rehabilitation services [10]. Typically, rehabilitation is based on a multidisciplinary approach that begins during acute care and continues in
an intensive functional rehabilitation unit (IFRU) and
after discharge. However, 37% of moderate-to-severe
cases are transferred to a rehabilitation unit post-stroke
[11]; the others return home with or without rehabilitation services [12,13], either because they live too far
from a rehabilitation center or because their motor recovery was judged adequate for a safe return home
[14,15]. Thus, there is a large number of individuals at
home who need rehabilitation following their stroke but
who do not have access to services [16]. Consequently,
their mobility and balance decline, creating a significant
risk for falls in this population.
The literature supports the need for outpatient rehabilitation services, at home or elsewhere for those
who return home, regardless of the severity of their sequelae [17]. Unfortunately, the precarious nature of services has been well-documented in the Canadian Best
Practice Recommendations for Stroke Care (updated
2013); it appears that the primary obstacle hindering best
practice application in stroke care is the lack of human resources. With this in mind, the Best Practices Expert
Consensus Panel prioritized certain recommendations, including facilitating outpatient and home-based rehabilitation services because of the inability of the healthcare
system to meet current demands [18]. Therefore, it is essential to improve accessibility to rehabilitation services,
as clearly indicated in the Quebec Homecare Support Policy [18,19].
In this context, new alternative approaches need to be
considered to deliver services at home. Telerehabilitation,
defined as a telehealth application that uses telecommunication technologies to provide rehabilitation services, is a
Page 2 of 9
new approach in the rehabilitation field. It has been identified as a very promising alternative tool that could help
improve access to healthcare services in general [20-25].
Furthermore, telerehabilitation has been identified as one
of the three telehealth application areas prioritized by the
Quebec Ministry of Health and Social Services [11]. A
main advantage of this intervention method is that it allows patients to receive rehabilitation in their homes without having to travel to get healthcare services. This way of
delivering services also addresses the shortage of professionals; with less time spent traveling, professionals can
spend more time treating, which in turn improves access
to services. It is therefore crucial to provide decisionmakers with evidence concerning the effectiveness of telerehabilitation applications.
Regardless of the rehabilitation delivery mode, the
choice and type of exercise program varies from one study
to the next. Recent studies have shown that a balance
retraining program based on Tai Chi movements improved balance in individuals at risk of falls [26,27]. A Tai
Chi-based exercise program, supervised by a physiotherapist, which uses movement repetition favoring directional
adjustments in space has been shown to be effective in improving balance in individuals with physical impairments,
including those presenting sequelae following a stroke.
Two studies conducted by our research group demonstrated similar results in frail, older individuals [28,29]. A
study conducted with older individuals with diabetes
found that a simple sequence of Tai Chi movements improved their balance and attention capacity [29]. Another
study conducted with frail, older individuals with balance
problems showed that a Tai Chi intervention had a protective effect on the incidence of falls: for every person
who had falls in the Tai Chi group, the conventional
physiotherapy group had 1.3 people who had falls [29].
Furthermore, the Tai Chi intervention appeared to delay
the onset of the first fall in older individuals, with 50% of
participants in the physiotherapy group falling once after
five months of follow-up, compared to after ten months of
follow-up for 50% of participants in the Tai Chi group
[30]. Even more interesting is the fact that these balance
retraining programs based on Tai Chi movements are
equally effective in older individuals following a stroke
[31,32]. In fact, the first large-scale study [31] (Tai Chi
group: n = 74; comparison group: n = 62) demonstrated
the effectiveness of Tai Chi in improving balance compared to a conventional exercise program in individuals
with chronic stroke. A second study [32] achieved the
same results with 18 patients. Moreover, in a pre-/postintervention study with no control group, 17 balance
impaired elders have undergone a structured, interactive,
and supervised Tai Chi class from their own homes
through a videoconferencing system to improve balance
and reduce fear of falling. The results demonstrated the
Tousignant et al. Trials 2014, 15:42
http://www.trialsjournal.com/content/15/1/42
intervention was effective for improving balance and
reducing fear of falling [33]. Finally, our pilot study demonstrated that Tai Chi practiced via supervised telerehabilitation was effective in improving balance and motor skills
in six patients post-stroke.
The principal aim of this clinical trial is to test the noninferiority of a Tai Chi-based exercise program, provided
via telerehabilitation compared to the same program provided in person at home, in terms of effectiveness for
retraining balance in individuals who have had a stroke
but do not require intensive functional rehabilitation.
More specifically, the objectives are to:
1) Verify whether the gains in both physical and
psychological capacities related to balance and
mobility of patients treated by Tai Chi via
telerehabilitation are not inferior to those receiving
the same treatment in person at home;
2) Verify if the gain in quality of life of patients treated
by Tai Chi via telerehabilitation is not inferior to the
gain of those receiving the same treatment in person
at home;
3) Verify if satisfaction with services received by
patients treated by Tai Chi via telerehabilitation
group is not inferior to satisfaction of those
receiving the same treatment in person at home;
4) Compare the costs associated with the provision of
the two types of services delivery, that is, via
telerehabilitation and in person at home.
Methods/Design
Study design
The design of choice to determine the effectiveness of
an experimental intervention compared to a standard
intervention is the randomized controlled trial (RCT).
Two groups will be formed: 1) telerehabilitation group,
and 2) home visits group. We will use this design while
considering that the prerequisites for undertaking a noninferiority RCT are met:
1) The plausibility that a balance retraining program
based on Tai Chi movements has been shown to
improve balance [34], and specifically in clients with
stroke [32,35].
2) The research procedures in telerehabilitation are
well established in real-life situations, from both
clinical and technological perspectives. Our team is
at the forefront of conducting studies in home-based
teletreatment following knee arthroplasty [30,36], in
speech therapy [37], and in individuals with chronic
obstructive pulmonary disease [38].
3) We conducted a pilot study in six patients post-stroke.
Figure 1 illustrates the research design and timeline.
Page 3 of 9
Participants
The study population of interest will be individuals who
have had a stroke and stayed in a hospital linked to one of
the following sites: 1) Sherbrooke site (Centre Hospitalier
Universitaire de Sherbrooke), 2) Montreal sites (Jewish
Rehabilitation Hospital, Institut de Réadaptation GingrasLindsay-de-Montreal and Centre de Santé et de Services
Sociaux Champlain-Charles-Le Moyne), and 3) Toronto
site (Sunnybrook Health Sciences Center). Special care
will be taken to ensure that participant eligibility will target individuals who have had a stroke and returned home
without requiring intensive rehabilitation. We will base
our selection on the Rankin classification [39] established
by the treating neurologist or trained therapist during the
hospitalization period. This classification system allows us
to assign individuals who have had a stroke to one of four
groups according to their level of functional impairment.
Patients with a Rankin score of 2 generally present with
mild impairments, maintain their autonomy and can perform all previous activities. Patients with a Rankin score
of 3 present with moderate impairments and generally require moderate assistance with their activities of daily living. These patients are usually sent home with or without
referral for physiotherapy services at home.
Therefore, a sample of participants aged 45 years and
older will be recruited based on the following inclusion
criteria: 1) have had a stroke with a Rankin score of 2 or 3;
2) not be referred to an IFRU and return home following
discharge from hospital; 3) understand instructions to
allow participation in evaluations and interventions; 4)
have a balance problem as evidenced by a score between
46 and 54 on the Berg Balance Scale [40]; 5) have a caregiver who would be available during the telerehabilitation
sessions to ensure safety during exercises; and 6) live in an
area served by high speed Internet. Excluded will be individuals who present with: 1) a previous stroke episode in
the last 12 months (other than the present one); 2) severe
body hemineglect; 3) significant hemianopsia visual problems accompanied by hemineglect; 4) uncontrolled medical problems; and 5) moderate to severe aphasia.
Participants will be recruited during the hospitalization
period by the team of treating nurses, physiotherapists
and neurologists at each of the three sites (Sherbrooke,
Montreal and Toronto). When the team decides that a patient will not require a referral to an IFRU and will return
home (inclusion criteria 1 and 2), they will verify inclusion
criteria 3 and 4 and exclusion criteria 1 to 5 from the
medical chart. If patients are eligible based on these criteria, the hospital team will ask if they agree to be contacted by a research associate. If they agree, a research
associate will visit them in hospital to inform them of the
project and ask them to participate. The research associate
will verify inclusion criteria 5 and 6. If a patient meets all
the criteria and is interested in participating in the study,
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Page 4 of 9
Figure 1 Research design and timeline.
they will be asked to sign the consent form previously approved by the ethics committee at each recruitment site.
Once included, participants will be randomly assigned
to either the telerehabilitation group or the home
visits group by the coordinator of each recruitment
site. This randomization will be performed using block
randomization of sizes 2 and 4 done by a computer. Block
size will not be known by the evaluators. This randomization will be performed following stratification
based on the Rankin score (2 or 3), a variable that is likely
to influence recovery prognosis. A system of numbered,
sealed envelopes will be put in place.
Ethics
The study is being conducted in accordance with the
Helsinki Declaration. It was approved by the Ethics Committee of each recruitment sites: 1) Sherbrooke - Centre
Hospitalier Universitaire de Sherbrooke and Centre de
Santé et de Services Sociaux de l’Institut Universitaire
de Gériatrie de Sherbrooke; 2) Montréal - Centre de
Recherche Interdisciplinaire en Réadaptation de Montréal
Métropolitain; 3) Longueuil - Centre de Santé et de Services Sociaux Champlain-Charles-Le Moyne; 4) Toronto Sunnybrook Hospital. It has also been registered under
www.clinicaltrials.gov (NCT01848080).
Interventions
A personalized exercise program based on Tai Chi was
developed by our team for previous studies aiming to
improve balance in older individuals with diabetes [28]
and in frail, older individuals with balance problems
[29]. This program was also used during the pilot study.
The exercise program consists of movements based on a
combination of alignments and body-specific orientations, weight transfers and changes in direction inspired
by Tai Chi [41]. The exercises do not require any physical interaction between the Tai Chi instructor and participants. Optimal treatment frequency for patients in
the subacute and chronic phases following a stroke is
twice a week, as suggested by a systematic review [42].
For both groups, the interventions will start immediately after discharge from hospital. The rehabilitation
exercise sessions will be conducted by a physiotherapist
trained in the practice of Tai Chi. The sessions will last
45 minutes and take place twice a week for eight weeks.
The only difference between the groups will be the delivery mode of the intervention, that is telerehabilitation or
home visits.
Outcomes
All evaluations will be completed in the research centers/
hospitals of the three sites and will last approximately
three hours. The first evaluation will be conducted at
baseline, prior to starting intervention (T1) to collect base
measures on the participants’ condition. A second evaluation will be conducted just after the two-month intervention (T2) and the third evaluation will be four months (T3)
following discharge from the hospital. All evaluations will
be carried out by evaluators trained in the standard procedures for all measures, who are independent and blinded
to the intervention. Specific directions will be provided to
the evaluators and the participants to ensure that intervention allocation remains anonymous.
To measure balance and functional mobility, the Community Balance and Mobility Scale (CB&M) [43-45] will
be used. This tool was developed for ambulatory individuals following a traumatic brain injury [43]. It has been
validated in individuals following a stroke [44,46]. It assesses 19 tasks. The items are rated on a six-point scale
(from 0 = unable to perform, to 5 = able to perform independently), for a maximum total score of 95 points. The
CB&M has demonstrated good intra-rater, inter-rater and
test-retest reliability (ICC = 0.98 for all three cases) and
high internal consistency (Cronbach’s alpha = 0.96) [43]. It
has good convergent validity with the Chedoke-McMaster
Stroke Assessment [47] for leg and foot (r = 0.61 and 0.63,
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respectively) and for lower extremity strength (r = 0.67)
[44]. Furthermore, the CB&M has been shown to be
sensitive to change from baseline at follow-up in
community-dwelling, ambulatory individuals post-stroke
(SRM (standardized response mean) = 0.83) [44]. In
addition, the Berg Balance Scale [42,48] will be used to
evaluate balance in patients. The Four-Squares Test will
also be used. This test consists of moving in different preset directions: forward, backward and to the sides. The
time required to complete the sequence is recorded. An
execution time greater than 15 seconds is predictive of
falling. This test has high inter-rater (ICC = 0.99), intrarater (ICC = 0.98) and test-retest (ICC = 0.98) reliability in
community-dwelling older individuals aged 65 years and
over [49]. Also, for predicting falls, this test has good
specificity ranging from 88% to 100% and a positive predictive value of 86% [49].
The physical abilities capacities measured will be:
1) walking speed, 2) walking endurance, 3) lower extremity strength, and 6) lower extremity movement capacity.
Each of these abilities plays an important role in achieving
optimal functional mobility. Walking speed will be evaluated using the Timed Up and Go test (TUG) [50]. The test
consists of standing up from a chair, walking a distance of
three meters, turning around and returning to the chair to
sit down again. The test is timed to measure walking
speed in seconds over a distance of six meters. The TUG
demonstrates good convergent construct validity with
moderate to strong correlations with walking using the
Tinetti test (r = 0.53) and walking speed (r = 0.66) in an elders population aged 65 years and over [51]. It has also
been shown that walking speed is related to use of gait
aids and fall frequency [52]. It is a measure sensitive to
change [53]. Walking endurance will be estimated by the
distance covered in meters during the Two-Minute Walk
Test [53,54]. The inter-rater and intra-rater reliability of
this test is high (ICC = 0.99) [50]. General lower extremity
strength will be measured with the Sit to Stand test (STS)
[55]. The time required to complete five successive ‘sit-tostand’ repetitions will be recorded [55,56]. The test-retest
reliability of the STS is high (ICC = 0.89) [57]. There is
also a strong correlation of the STS with walking speed
over five meters (r = −0.66) and lower extremity strength
(r = 0.47) [58]. Lower extremity movement capacity and
postural control will be evaluated using the ChedokeMcMaster Stroke Assessment [59]. The impairment inventory determines the presence and severity of physical
deficits, and allows patients to be classified according to
Brunnstrom’s seven stages of motor recovery. This tool
has good intra- and inter-rater reliability (ICC = 0.98 and
0.97, respectively) and good construct validity (r > 0.60
with different aspects of the Fugl Meyer test) [47].
Two main aspects of psychological capacities measured will be 1) fear of falling, and 2) self-efficacy. The
Page 5 of 9
simplified version of the Activities-specific Balance
Confidence (ABC) scale [60] questionnaire (ABC-S) will
measure fear of falling. This questionnaire includes 15
questions rated on a four-point Likert scale and evaluates an individual’s balance confidence during a series of
daily activities [60,61]. The ABC-S has strong internal
consistency (Cronbach’s alpha = 0.86) good convergent
validity with significant associations with balance and
occurrence of falls [60]. Self-efficacy when faced with
difficult life situations will be evaluated using the Generalized Self-Efficacy Scale (GSES) [60]. This questionnaire
is a ten-item scale that uses a four-point Likert scale
(from 1 = not true at all, to 4 = completely true) to assess
whether an individual believes that their actions are
responsible for their successful outcomes. This scale has
been shown to have excellent internal consistency
(Cronbach’s alpha = 0.86) [62].
Quality of life will be measured using the Reintegration to Normal Living Index (RNLI) [63]. This tool consists of 11 items ranked on a three-point Likert scale.
The total score ranges from 0 to 22, with higher scores
depicting lower quality of life. The psychometric properties range from very good to excellent with good internal
consistency (Cronbach’s alpha = 0.90) and good testretest reliability (r = 0.83) [63]. The construct validity of
this tool has been examined in a post-stroke population
and shows excellent correlations with the Frenchay Activities Index (r = 0.69) and the Short Form 36 Health
Survey (r = 0.74) [64].
Participant satisfaction with the intervention received
will be evaluated using the Health Care Satisfaction
Questionnaire, a questionnaire developed and validated
in French [65]. The satisfaction construct is determined
by three distinct factors which include satisfaction with:
1) the therapist relationship, 2) the services provided,
and 3) the organization of services. This tool includes 26
questions, scored on a four-point Likert scale. The total
score is calculated based on average satisfaction for the
three factors, with higher scores indicating higher levels
of satisfaction. Test-retest reliability is documented by
an ICC of 0.72 and internal consistency by a Cronbach’s
alpha of 0.93 for the entire scale [65].
A modified version of the ‘Cost analysis of telemedicine’
table from the University of Minnesota [66] will help tabulate the costs associated with the teletreatments. These
costs will be calculated to establish a cost differential (that
is, cost-effectiveness) between the two different types of
intervention. The method for collecting this data has
already been tested in a previous study [67]. The variables
related to the total cost include those associated with the
actual intervention (for example, direct and indirect time
for the intervention, professionals’ travel time to the participants’ homes, telerehabilitation equipment, and Internet service including installation and set-up).
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The typical sociodemographic (for example, age, sex,
marital status, living environment, education, primary occupation) and clinical characteristics (for example, diagnosis, gait aid, medications, self-rated health, co-morbidities)
will be collected using an in-house questionnaire, with the
exception of comorbidities for which the Functional Comorbidity Index will be used [68].
The level of impairment post-stroke will be measured
by the National Institute of Health Stroke Score (NIHSS)
[69,70]. This questionnaire, administered by a healthcare
professional, includes 15 items to evaluate patients in the
acute post-stroke phase. It demonstrates good internal
consistency (Cronbach’s alpha > 0.5) [71], good inter-rater
(ICC = 0.69) and test-retest (ICC = 0.66 to 0.77) reliability
in a post-stroke population [69] and good convergent validity (r = 0.74 with lesion volume seven days post-stroke)
[70]. The level of cognitive impairment will be measured
using the Montreal Cognitive Assessment (MoCA) [72].
This test evaluates attention, concentration, executive
functions, memory, language, visioconstructive capacities,
abstraction capacities, calculation and orientation. The
maximum score of 30 corresponds to no cognitive problems. The internal consistency of this test is good
(Cronbach’s alpha = 0.83) and test-retest reliability is excellent (ICC = 0.92) [73]. The correlation between the
MoCA and Mini-Mental State Examination scores has
been shown to be excellent (r = 0.87) [73]. Noteworthy
is the fact that this test will be completed during the
participant recruitment phase.
Statistical methods
We expect to recruit 240 participants, that is, 120 per
group. Allowing for a drop-out rate of 10%, this sample
size will provide a power of 80% to demonstrate the
non-inferiority of Tai Chi provided by telerehabilitation
compared to Tai Chi provided in person at home, with a
two-group one-sided test at the 2.5% level (nQuery
Advisor 7.0; Statistical Solutions, Boston, MA). For this
calculation, the non-inferiority limit was set at four points
on the CB&M scale and the standard deviation of the gain
was estimated to be 10.4, based on findings from Knorr
[44], since SRM = MeanGAIN/sGAIN implies that:
SGAIN ¼ MeanGAIN =SRM ¼ ð51:3−42:7Þ=0:83
First, we will describe the characteristics of each group
pre-intervention using averages and standard deviations
(continuous variables) or percentages (categorical variables). The groups will then be compared using a t-test
or chi-squared test. If the groups differ on certain characteristics pre-intervention despite randomization, subsequent analyses will account for these differences.
Primary analysis will aim to test the non-inferiority of
Tai Chi provided via telerehabilitation compared to Tai
Page 6 of 9
Chi provided in person at home as evaluated by score
gains on the CB&M questionnaire from T1 to T2. Delivery by telerehabilitation will be regarded as non-inferior
to in person home delivery if the upper limit of the
unilateral confidence interval around the difference in
gains between the two groups is less than 4. This noninferiority limit was set below the CB&M’s minimal clinically significant difference of five points. It is recommended
to choose a non-inferiority limit less than the difference
judged to be clinically significant [74,75].
The same analytical strategy will be used to evaluate
and compare the effectiveness of the interventions on
secondary variables and to compare maintenance over
time (that is, the confidence interval around the difference between the two groups from T1 to T3) across all
variables. A more conservative level of significance will
be used to account for the numerous tests.
All analyses will first be performed according to the
treatment received (per protocol = PP) and according to
the assigned group (intention to treat = ITT), requiring
that non-inferiority be shown in both cases since ITT
analyses increase the chance of declaring non-inferiority
if the two delivery modes produce a similar pattern of
withdrawal, while PP analyses bias towards the null in
presence of a different pattern of withdrawal [74]. For
the ITT analysis, the effects of withdrawal or low levels
of compliance will be explored with sensitivity analyses,
where the missing data will be replaced with extreme
values (that is, no change following treatment - the most
favorable change noted in the study). Any non-robustness
of results revealed by the comparison of strategies will be
noted and the caveats will be mentioned in the discussion
of results. All analyses will be conducted at the end of the
study since the proposed treatments are of short duration
and involve minimal risk to the participants.
The economic analysis will be a type of costminimization study [76]. Assuming that the effectiveness
will be the same in the dependent variable (CB&M), the
cost will be determined for the two groups and the cost
differential will be established.
Discussion
This trial is the first large-scale study to evaluate the noninferiority of telerehabilitation versus home visits in patients with mild to moderate balance impairment poststroke. Confirmation to recruit as many as 240 patients
post-stroke with our inclusion/exclusion criteria is based
on the 2010 to 2011 statistics for each recruitment site: 1)
Centre Hospitalier Universitaire de Sherbrooke (269 participants admitted following a stroke, including 59 who
returned home upon discharge); 2) Jewish Rehabilitation
Hospital (277 referrals for patients post-stroke); 3) Centre
de Santé et de Services Sociaux Champlain-Charles-Le
Moyne (106 participants admitted following a stroke,
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including 60 who returned home upon discharge); 4)
Toronto (189 participants admitted following a stroke, including 49 who returned home upon discharge). These
well-documented statistics proved the realism of the scope
of the study.
Telehealth, which includes telerehabilitation, is seen as
a method to provide care to the population. Considering
that the criteria for quality of care remain the same regardless of whether the care is provided by telehealth or
other means, the evaluation framework of the proposed
research is based on the theoretical construct of quality
of care. Without formal definition [77], quality of care
encompasses two components: 1) the viewpoint of the
patient who considers the notions of accessibility and effectiveness as essential [78]; and 2) the viewpoint of the
professional for whom the patient-doctor relationship [79],
efficiency and reliability are of key importance. Several
conceptual models for evaluating quality of care in the
literature include the Donabedian [80], Total Quality Management [81], Quality-Caring [82], ORYX [80], HEDIS [83]
and CONQUEST [80] models. In this research project, the
conceptual evaluation model used will be the Donabedian
model [84]. Given the objectives of this project, the study
aims to answer specific questions related to the effectiveness of using telerehabilitation to improve quality of care
for older individuals. This model defines quality of care as
a combination of three elements: structure, process and
outcome. The notions of ‘quality’ and ‘performance’ are
directly related to the organizational structure of the
healthcare system and its management processes. The term
‘outcome’ corresponds to the quality of care provided to
patients, the performance of the healthcare system in offering care and the associated costs. Given the nature of this
research, emphasis will be placed on the evaluation of telerehabilitation outcomes.
Concerning internal validity, we will control for potential selection bias by assigning participants to either the
telerehabilitation or the control (home visits) group by
randomization and by comparing participants’ characteristics in each group before the intervention. If the groups
have different characteristics pre-intervention despite
randomization, subsequent analysis will account for these
differences. Information bias will be controlled by using
standardized measures and by calibrating all the assessors
for each assessment.
This study will verify the non-inferiority of in-home telerehabilitation compared to home visits for patients with
mild to moderate balance problems post-stroke. Our hypothesis is that in-home telerehabilitation will be shown
to be a good alternative to ensure continuity of rehabilitation services and their accessibility in the community.
Trial status
Recruitment has just begun (September 2013).
Page 7 of 9
Abbreviations
ABC-S: Activities-specific Balance Confidence scale (Simplified version);
CB&M: Community Balance and Mobility Scale; GSES: Generalized Self-Efficacy
Scale; ICC: intra-class correlation; IFRU: Intensive Functional Rehabilitation
Unit; ITT: intention to treat; MoCA: Montreal Cognitive Assessment;
NIHSS: National Institute of Health Stroke Score; PP: per protocol;
RCT: randomized controlled trial; RNLI: Reintegration to Normal Living Index;
SRM: standardized response mean; STS: Sit to Stand test; TUG: Timed Up and
Go test.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
All authors participated in the conception and design of the study. MT is
responsible for telerehabilitation expertise. HC and KB are responsible for fall
prevention, balance expertise and intervention program. SG and RS are the
neurologists taking care of recruitment. DK carries out the cost evaluation.
MFD carries out the statistical analysis. JMB and CD supervised the team of
research agents at their sites. All authors read and approved the final
manuscript.
Acknowledgements
This research project is support by a grant received from the Canadian
Institute of Health Research (CIHR), CIHR grant #272977.
Author details
1
Université de Sherbrooke, Sherbrooke, QC, Canada. 2Research Center on
Aging, University Institute of Geriatrics of Sherbrooke, Sherbrooke, QC,
Canada. 3Université de Montréal, Montreal, QC, Canada. 4University of
Toronto, Toronto, ON, Canada. 5Sunnybrook Stroke Research Unit, Toronto,
ON, Canada.
Received: 3 October 2013 Accepted: 22 January 2014
Published: 30 January 2014
References
1. Sacco RL, Benjamin EL, Broderick JP, Dyken M, Eston JD, Feinberg WM,
Goldstein LB, Gorelick PB, Howard G, Kittner SJ, Manolio TA, Whisnant JP,
Wolf PA: American Heart Association Prevention Conference. IV.
Prevention and Rehabilitation of Stroke. Risk factors. Stroke 1997,
28(7):1507.
2. Dimyan MA, Cohen LG: Neuroplasticity in the context of motor
rehabilitation after stroke. Nat Rev Neurol 2011, 7(2):76.
3. Forster A, Young J: Stroke rehabilitation: can we do better? BMJ 1992,
305(6867):1446.
4. Wada N, Sohmiya M, Shimizu T, Okamoto K, Shirakura K: Clinical analysis of
risk factors for falls in home-living stroke patients using functional
evaluation tools. Arch Phys Med Rehabil 2007, 88(12):1601.
5. Stolze H, Klebe S, Zechlin C, Baecker C, Friege L, Deuschl G: Falls in
frequent neurological diseases - prevalence, risk factors and etiology.
J Neurol 2004, 251(1):79.
6. Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM, Women's Health and
Aging Study: Risk factors for falling in home-dwelling older women with
stroke: the Women's Health and Aging Study. Stroke 2003, 34(2):494.
7. Simpson LA, Miller WC, Eng JJ: Effect of stroke on fall rate, location and
predictors: a prospective comparison of older adults with and without
stroke. PloS One 2011, 6(4):e19431.
8. Tinetti ME, Baker DI, Dutcher J, Vincent JE, Rozett RT: Reducing the risk of
falls among older adults in the community. Berkeley, CA: Peaceable Kingdom
Press; 1997.
9. Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson
LM, Lamb SE: Interventions for preventing falls in older people living in
the community. Cochrane Database Syst Rev 2012, 9, CD007146.
10. Lincoln NB, Gladman JR, Berman P, Luther A, Challen K: Rehabilitation
needs of community stroke patients. Disabil Rehabil 1998, 20(12):457–463.
11. Canadian Stroke Network: La qualité des soins de l'AVC au Canada. http://
www.canadianstrokenetwork.ca/wp-content/uploads/2011/06/QoSC-FR1.pdf.
12. Bates B, Choi JY, Duncan PW, Glasberg JJ, Graham GD, Katz RC, Lamberty K,
Reker D, Zorowitz R, US Department of Defense; Department of Veterans
Affairs: Veterans Affairs/Department of Defense Clinical Practice
Tousignant et al. Trials 2014, 15:42
http://www.trialsjournal.com/content/15/1/42
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
Guideline for the Management of Adult Stroke Rehabilitation Care:
executive summary. Stroke 2005, 36(9):2049.
Edwards DF, Hahn MG, Baum CM, Perlmutter MS, Sheedy C, Dromerick AW:
Screening patients with stroke for rehabilitation needs: validation of the
post-stroke rehabilitation guidelines. Neurorehabil Neural Repair 2006, 20(1):42.
Mayo NE, Wood-Dauphinee S, Côté R, Durcan L, Carlton J: Activity,
participation, and quality of life six months poststroke. Arch Phys Med
Rehabil 2002, 83(8):1035.
Chuang KY, Wu SC, Ma AH, Chen YH, Wu CL: Identifying factors associated
with hospital readmissions among stroke patients in Taipei. J Nurs Res
2005, 13(2):117.
Thorsen AM, Holmqvist LW, de Pedro-Cuesta J, von Koch L: A randomized
controlled trial of early supported discharge and continued rehabilitation
at home after stroke: five-year follow-up of patient outcome.
Stroke 2005, 36(2):297.
Lindsay P, Bayley M, Hellings C, Hill M, Woodbury E, Philips S:
Recommandations canadiennes pour les pratiques optimales de soins
de l'AVC (mise à jour de 2008) - Sommaire. CMAJ 2008, 179(12):SF1.
Ministère de la santé et des services sociaux du Québec: Chez soi: le
premier choix. La politique de soutien à domicile. http://publications.
msss.gouv.qc.ca/acrobat/f/documentation/2002/02-704-01.pdf.
Ministère de la santé et des services sociaux du Québec: Chez soi: le
premier choix. Précisions pour favoriser l'implantation de la politique de
soutien à domicile. http://publications.msss.gouv.qc.ca/acrobat/f/
documentation/2004/04-704-01.pdf.
Hogenbirk JC, Brockway PD, Finley J, Jennett P, Yeo M, Parker-Taillon D,
Pong RW, Szpilfogel CC, Reid D, MacDonald-Rencz S, Cradduck T: Framework
for Canadian telehealth guidelines: summary of the environmental scan.
J Telemed Telecare 2006, 12(2):64.
Pineau G, Moqadem K, St-Hilaire C, Levac E, Hamel BT: Lignes directrices
cliniques et normes technologiques en téléréadpatation, in Agences des
technologies et des modes d'intervention en santé. http://www.inesss.qc.
ca/fileadmin/doc/AETMIS/Rapports/Telesante/2006_03_res_fr.pdf.
Brennan D, Mawson S, Brownsell S: Telerehabilitation: enabling the
remote delivery of healthcare, rehabilitation, and self management.
Stud Health Technol Inform 2009, 145:231.
McCue M, Fairman A, Pramuka M: Enhancing quality of life through
telerehabilitation. Phys Med Rehabil Clin N Am 2010, 21(1):195.
Theodoros D, Russell T: Telerehabilitation: current perspectives.
Stud Health Technol Inform 2008, 131:191.
Romanow RJ: L'Avenir des soins de santé au Canada. http://publications.
gc.ca/collections/Collection/CP32-85-2002F.pdf.
Wong AM, Yu-Cheng P, Ching L, Shu-Chun H, Yin-Chou L, Shih-Wei C: Is Tai
Chi Chuan effective in improving lower limb response time to prevent
backward falls in the elderly? Age (Dordr) 2009, 31(2):163.
Sattin RW, Sley KA, Wolf SL, Chen Y, Kutner MH: Reduction in fear of falling
through intense Tai Chi exercise training in older, transitionally frail
adults. J Am Geriatr Soc 2005, 53:1168.
Corriveau H, Sveistrup H, Tousignant M: Effects of Tai Chi Exercise on Clinical
Measures of Balance and Attention Demand in Older Individuals with
Moderate Diabetic Peripheral Neuropathy. Burlingon (USA): Proceedings of
Symposium International of gait and posture: 3 to 5 July 2007; 2007.
Tousignant M, Corriveau H, Roy PM, Desrosiers J, Dubuc N, Hébert R:
Efficacy of supervised Tai Chi exercises versus conventional physical
therapy exercises in fall prevention for frail older adults: a randomized
controlled trial. Disabil Rehabil 2012, 35(17):1429.
Tousignant M, Corriveau H, Roy PM, Desrosiers J, Dubuc N, Hébert R,
Tremblay-Boudreault V, Beaudoin AJ: The effect of supervised Tai Chi
intervention compared to a physiotherapy program on fall-related clinical
outcomes: a randomized clinical trial. Disabil Rehabil 2012, 34(3):196.
Au-Yeung S, Hui-Chan CW, Tang JC: Short-form Tai Chi improves standing
balance of people with chronic stroke. Neurorehabil Neural Repair 2009,
23(5):515–522.
Har J, Kanner H, Gilboa-Mayo R, Haroeh-Peer O, Rozenthul-Sorokin N, Eldar
R: Tai Chi Chuan practice in community-dwelling persons after stroke.
Int J Rehabil Res 2004, 27(4):303.
Wu G, Keyes LM: Group tele-exercise for improving balance in elders.
Telemed J E Health 2006, 12:561–570.
Wooton A: An integrative review of Tai Chi research: an alternative form
of physical activity to improve balance and prevent falls in older adults.
Orthop Nurs 2010, 29(2):108.
Page 8 of 9
35. Bashshur R, Shannon G, Krupinski E, Grigsby J: The taxonomy of
telemedicine. Telemed J E Health 2011, 17(6):484.
36. Tousignant M, Boissy P, Moffet H, Corriveau H, Cabana F, Marquis F, Simard
J: Patients' satisfaction of healthcare services and perception with inhome telerehabilitation and physiotherapists' satisfaction toward
technology for post-knee arthroplasty: an embedded study in a
randomized trial. Telemed J E Health 2011, 17(5):376.
37. Dechêne L, Tousignant M, Boissy P, Macoir J, Héroux S, Hamel M, Brière S,
Pagé C: Simulated in-home teletreatment for anomia. Int J Telerehabil
2011, 3(2):3.
38. Tousignant M, Marquis N, Pagé C, Imukuze N, Métivier A, St-Onge V,
Tremblay A: In-home telerehabilitation for older persons with chronic
obstructive pulmonary disease: a pilot Study. Int J Telerehabil 2012, 4(1):7.
39. Lai SM, Duncan PW: Stroke recovery profile and the Modified Rankin
assessment. Neuroepidemiology 2001, 20(1):26.
40. Berg K, Wood-Dauphinee S, Williams J: The Balance Scale: reliability
assessment with elderly residents and patients with an acute stroke.
Scand J Rehabil Med 1995, 27(1):27.
41. Wolf SL, Coogler C, Xu T: Exploring the basis for Tai Chi Chuan as a
therapeutic exercise approach. Arch Phys Med Rehabil 1997, 78(8):886.
42. Lubetzky-Vilnai A, Kartin D: The effect of balance training on balance
performance in individuals poststroke: a systematic review. J Neurol Phys
Ther 2010, 34(3):127.
43. Howe JA, Inness EL, Venturini A, Williams JI, Verrier MC: The Community
Balance and Mobility Scale - a balance measure for individuals with
traumatic brain injury. Clin Rehabil 2006, 20(10):885.
44. Knorr S, Brouwer B, Garland SJ: Validity of the Community Balance and
Mobility Scale in community-dwelling persons after stroke. Arch Phys Med
Rehabil 2010, 91(6):890.
45. Salbach NM, Mayo NE, Higgins J, Ahmed S, Finch LE, Richards CL:
Responsiveness and predictability of gait speed and other disability
measures in acute stroke. Arch Phys Med Rehabil 2001, 82(9):1204.
46. Rocque R, Bartlett D, Brown J, Garland SJ: Influence of age and gender of
healthy adults on scoring patterns on the Community Balance and
Mobility Scale. Physiother Can 2005, 57:285.
47. Gowland C, Stratford P, Ward M, Moreland J, Torresin W, Van Hullenaar S,
Sanford J, Barreca S, Vanspall B, Plews N: Measuring physical impairment
and disability with the Chedoke-McMaster Stroke Assessment.
Stroke 1993, 24(1):58.
48. Blum L, Korner-Bitensky N: Usefulness of the Berg Balance Scale in stroke
rehabilitation: a systematic review. Physical therapy 2008, 88(5):559.
49. Dite W, Temple VA: A clinical test of stepping and change of direction to
identify multiple falling older adults. Arch Phys Med Rehabil 2002,
83(11):1566.
50. Podsiadlo D, Richardson S: The timed ‘Up & Go’: a test of basic functional
mobility for frail elderly persons. J Am Geriatr Soc 1991, 39(2):142.
51. Lin MR, Hwang HF, Hu MH, Wu HD, Wang YW, Huang FC: Psychometric
comparisons of the timed up and go, one-leg stand, functional reach,
and Tinetti balance measures in community-dwelling older people. J Am
Geriatr Soc 2004, 52(8):1343.
52. Wade DT, Wood VA, Heller A, Maggs J, Langton Hewer R: Walking after
stroke. Measurement and recovery over the first three months. Scand J
Rehabil Med 1987, 19(1):25.
53. Dean CM, Richards CL, Malouin F: Walking speed over 10 meters
overestimates locomotor capacity after stroke. Clin Rehabil 2001, 15(4):415.
54. Wade DT: Measurement in neurological rehabilitation. Curr Opin Neurol
Neurosurg 1992, 5(5):682.
55. Bohannon RW: Sit-to-stand test for measuring performance of lower
extremity muscles. Percept Mot Skills 1995, 80(1):163.
56. Csuka M, McCarty DJ: Simple method for measurement of lower
extremity muscle strength. Am J Med 1985, 78(1):77.
57. Lord SR, Murray SM, Chapman K, Munro B, Tiedemann A: Sit-to-stand
performance depends on sensation, speed, balance, and psychological
status in addition to strength in older people. J Gerontol A Biol Sci Med Sci
2002, 57(8):M539.
58. Newcomer KL, Krug HE, Mahowald ML: Validity and reliability of the
timed-stands test for patients with rheumatoid arthritis and other
chronic diseases. J Rheumatol 1993, 20(1):21.
59. Valach L, Signer S, Hartmeier A, Hofer K, Steck GC: Chedoke-McMaster
stroke assessment and modified Barthel Index self-assessment in
patients with vascular brain damage. Int J Rehabil Res 2003, 26(2):93.
Tousignant et al. Trials 2014, 15:42
http://www.trialsjournal.com/content/15/1/42
60. Filiatrault J, Gauvin L, Fournier M, Parisien M, Robitaille Y, Laforest S,
Corriveau H, Richard L: Evidence of the psychometric qualities of a
simplified version of the Activities-specific Balance Confidence scale for
community-dwelling seniors. Arch Phys Med Rehabil 2007, 88(5):664.
61. Jorstad EC, Hauer K, Becker C, Lamb SE, ProFaNE Group: Measuring the
psychological outcomes of falling: a systematic review. J Am Geriatr Soc
2005, 53(3):501.
62. Scholz U, Gutiérrez-Doña B, Sud S, Schwarzer R: Is general self-efficacy a
universal construct? Psychometric findings from 25 countries. Eur J
Psychol Ass 2002, 18(3):242.
63. Wood-Dauphinee SL, Opzoomer MA, Williams JI, Marchand B, Spitzer WO:
Assessment of global function: the Reintegration to Normal Living Index.
Arch Phys Med Rehabil 1988, 69(8):583.
64. Daneski K, Coshall C, Tilling K, Wolfe CD: Reliability and validity of a postal
version of the Reintegration to Normal Living Index, modified for use
with stroke patients. Clin Rehabil 2003, 17(8):835.
65. Gagnon M, Hebert R, Dubé M, Dubois MF: Development and validation of
an instrument measuring individual empowerment in relation to
personal health care: the Health Care Empowerment Questionnaire
(HCEQ). Am J Health Promot 2006, 20(6):429.
66. Chapko MK, Hedrick S: Cost as a study outcome: sensitivity of study
conclusions to the method of estimating cost. Med Care 1999,
37(4 Suppl Va):AS37.
67. Tousignant M, Moffet H, Boissy B, Cooriveau H, Cabana F, Marquis F: A
randomized controlled trial of home telerehabilitation for post-knee
arthroplasty. J Telemed Telecare 2011, 17(4):195.
68. Groll DL, To T, Bombardier C, Wright JG: The development of a
comorbidity index with physical function as the outcome. J Clin
Epidemiol 2005, 58(6):595.
69. Brott T, Adams JR, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J,
Holleran R, Eberle R, Hertzberg V: Measurements of acute cerebral
infarction: a clinical examination scale. Stroke 1989, 20:864–870.
70. Lyden P, Brott T, Tilley B, Welch KM, Mascha EJ, Levine S, Haley EC, Grotta J,
Marler J: Improved reliability of the NIH Stroke Scale using video training.
NINDS TPA Stroke Study Group. Stroke 1994, 25(11):2220.
71. Goldstein LB, Bertels C, Davis JN: Interrater reliability of the NIH stroke
scale. Arch Neurol 1989, 46(6):660.
72. Pendlebury ST, Cuthbertson FC, Welch SJ, Mehta Z, Rothwell PM:
Underestimation of cognitive impairment by Mini-Mental State Examination
versus the Montreal Cognitive Assessment in patients with transient ischemic
attack and stroke: a population-based study. Stroke 2010,
41(6):1290.
73. Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I,
Cummings JL, Chertkow H: The Montreal Cognitive Assessment, MoCA: a
brief screening tool for mild cognitive impairment. J Am Geriatr Soc 2005,
53(4):695.
74. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG, CONSORT Group:
Reporting of noninferiority and equivalence randomized trials: extension